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    Summary
    EudraCT Number:2021-002893-20
    Sponsor's Protocol Code Number:2021/0188/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-10-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-002893-20
    A.3Full title of the trial
    Impact of dapagliflozin on vascular function in chronic kidney disease patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of dapagliflozin on vascular function in chronic kidney disease patients
    A.3.2Name or abbreviated title of the trial where available
    DAPA-VASC
    A.4.1Sponsor's protocol code number2021/0188/HP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Rouen
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointBlot Julien
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.5Fax number+33232888287
    B.5.6E-mailsecretariat.drc@chu-rouen.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name FORXIGA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic kidney disease patients
    E.1.1.1Medical condition in easily understood language
    chronic kidney disease patients
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that 12-week treatment with dapagliflozin improves endothelium-dependent flow-mediated dilatation of peripheral conduit arteries during short-term increase in blood flow in chronic kidney disease patients
    E.2.2Secondary objectives of the trial
    To demonstrate that 12-week treatment with dapagliflozin improves endothelium-dependent flow-mediated dilatation of peripheral conduit arteries during sustained increase in blood flow in chronic kidney disease patients

    - To demonstrate that 12-week treatment with dapagliflozin improves the bioavailability of endothelial vasodilating factors in chronic kidney disease patients
    - To demonstrate that 12-week treatment with dapagliflozin reduces oxidative stress and inflammation in chronic kidney disease patients
    - To demonstrate that 12-week treatment with dapagliflozin improves arterial stiffness and cardiovascular coupling in chronic kidney disease patients
    - To demonstrate that 12-week treatment with dapagliflozin improves cardiac function in chronic kidney disease patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. - Chronic kidney disease (eGFR ≥ 25 and ≤ 60 mL/min/1.73m² by CKD-EPI)
    2. - Age ≥ 18 years
    3. - Receiving a stable dose of an ACE inhibitor or ARB for at least 12 weeks before screening or patients who were documented to be unable to take angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
    4. Patient having read and understood the information letter and signed the Informed Consent Form
    5. For women:
    a. Women of childbearing potential :
    i. Effective contraception according to CTFG contraception recommendations (V1.1 21/09/2020) since at least 4 weeks before randomization and during treatment,
    and;
    ii. Negative blood pregnancy test;
    b. Women surgically sterile (absence of ovaries and/or uterus);
    c. Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
    Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide.

    6. Patient able to comply with the study protocol, in the investigator’s judgment
    7. Patient affiliated with, or beneficiary of a social security (health insurance) category.
    E.4Principal exclusion criteria
    1. Type 1 and type 2 diabetes (fasting glycemia ≥ 126 mg/dL or use of oral hypoglycemic agents or insulin)
    2. Recessive or autosomal dominant polycystic kidney disease
    3. Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
    4. Lupus nephritis
    5. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
    6. History of organ transplantation
    7. Body weight > 35 kg/m²
    8. Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
    9. Receiving phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil or other) or riociguat (due to the risk of hypotension potentiation with GTN spray).
    10. Patients with NYHA class IV congestive heart failure at the time of enrolment
    11. Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
    12. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
    13. Active malignancy requiring treatment at the time of enrolment or is planned to undergo any treatment after randomization
    14. Severe hepatic impairment (Child-Pugh class C)
    15. History of frequent genital mycotic infections (> 2 during the last 12 months)
    16. Current pregnancy OR women who are breast-feeding
    17. Contraindications to NATISPRAY® 0.30mg/dose, solution for oral spray :
    - Hypersensitivity to nitrates or to any of the excipients,
    - State of shock, severe hypotension,
    - In combination with sildenafil, taladafil, vardenafil, avanafil and riociguat
    - Obstructive cardiomyopathy,
    - Inferior site myocardial infarction with extension to the right ventricle, acute phase, except when there is a sign of left ventricular failure,
    - Intracranial hypertension

    18. - Contra-indication to FORXIGA 10 mg film-coated tablets: hypersensitivity to dapagliflozin or to any of the excipients
    19. - Participation in another clinical study with an investigational product during the last 4 weeks prior to enrolment
    E.5 End points
    E.5.1Primary end point(s)
    Change in the magnitude of brachial artery flow-mediated dilatation in response to reactive hyperemia after 12-week treatment with dapagliflozin or placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    84 days
    E.5.2Secondary end point(s)
    - Change in the magnitude of radial artery flow-mediated dilatation in response to hand skin heating after 12-week treatment with dapagliflozin or placebo
    - Change in the plasma release of nitric oxide and epoxyeicosatrienoic acids induced by hand skin heating after 12-week treatment with dapagliflozin or placebo
    - Change in the plasma levels of pro-oxidant and pro-inflammatory lipid mediators 12-week treatment with dapagliflozin or placebo
    - Change in carotid artery elastic modulus, carotid-to-femoral pulse wave velocity and aortic augmentation index after 12-week treatment with dapagliflozin or placebo
    - Change in cardiac output, stroke volume, ejection fraction and left ventricular end-systolic elastance after 12-week treatment with dapagliflozin or placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    84 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months17
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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